4.2 Evaluation of markers and technologies
Main inclusion criteria
Testing and evaluation of markers and technologies in humans for use in detection, diagnosis, prediction, prognosis and monitoring in clinical, community or applied settings including
- assessment of sensitivity, efficacy, specificity, predictive and prognostic value, reproducibility and safety
- medical devices, imaging, diagnostic and predictive tests
- evaluation of diagnostic models, methods and methodologies in clinical or applied settings
Advice on research activities
Includes clinical and applied testing in humans, once verified in the laboratory, often in a trial or studies that involve a group of people.
Excludes pre-clinical investigation of potential diagnostics, which can include patient samples if they are being used in the diagnostic development phase. Such studies should be coded 4.1 Marker discovery.
Full name of code
|Short name||Unique ID|
|4.2 Evaluation of markers and technologies||4.2 Marker evaluation||
Related external links
Common Scientific Outline (CSO) – 4.2 Technology and/or Marker Evaluation with respect to Fundamental Parameters of Method